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Roswell Biotechnologies Enters Critical Phase of Industrializing Molecular Sensor Production


This story has been updated to include additional information from Roswell Biotechnologies.

NEW YORK – Roswell Biotechnologies, a startup using silicon chips to detect biological molecules, has achieved proof of concept and is finalizing designs for its electronic sensors.

The firm said it is on track for the commercial release of its platform by the end of 2021. Applications include rapid molecular testing, DNA sequencing, nucleic acid detection, as well as antigen and antibody detection. Roswell officials added that they believe the platform can contribute to COVID-19 diagnostics and respiratory disease diagnosis. DNA data storage is another potential application.

While Roswell has been overly optimistic in the past about how soon its platform would be available, officials said this time would be different. "What has changed is us getting the commercialization process online," Roswell CEO and Cofounder Paul Mola said. "We now have a chemistry actually compatible with complementary metal oxide semiconductor (CMOS) chips" that is able to discriminate and read bases. Roswell later added that it has achieved sequencing of all four bases.

Large-scale manufacturing, then, is the crux of the matter for Roswell. "One of the significant hurdles to commercializing molecular electronics is the need for costly customized solutions," Roswell CSO and Cofounder Barry Merriman said. The firm has signed a deal with Belgian silicon chip maker Imec to design the industrial process that can fabricate those electronics using standard lithographic techniques.

The final product's sequencing technical capabilities, as well as its cost, will depend greatly on how well the partners can translate the chip design and how well Roswell can re-engineer its chemistries to fit the new chips.

Since 2014, San Diego-based Roswell has been developing Electronic Nano-Device Sequencing (ENDSeq), a technology that integrates a polymerase into an electronic circuit and measures changes in current when the enzyme incorporates bases into a DNA strand. The tech is comparable to nanopore-based sensing methods, such as Oxford Nanopore Technologies', which detects current changes, although Roswell's tech is nearly entirely silicon based. Thermo Fisher Scientific's IonTorrent and Illumina's iSeq platforms also use silicon chips.

So far, Roswell has raised $32 million in Series A financing in January 2019 and is not considering raising more for the time being. "At this point we have sufficient funding to take us through sometime next year, when we can start to consider other options," Mola said.

The company is hiring, although the COVID-19 pandemic has put a damper on talent acquisition for now, Mola said.

While the technical foundations for molecular electronics have been laid for years, getting it to work has taken some time. In January 2018, Mola said Roswell would have a system ready for early-access users by the end of that year and would begin commercializing it in 2019.

Roswell still has the goal of reaching a $100 price point for a human genome, deployed in an easy-to-use, rapid workflow. But speed, accuracy, and cost will be dictated by the final chip design, Merriman said. Roswell has gotten the chip and chemistry to work together internally, officials said, but now needs to scale its chip production into a commercially-viable process. Imec, Merriman said, is "the only place on Earth that is set up to port this."

"We select customers based on the technical scope of work with outlook on the long-term potential of the project," an Imec spokesperson said in an email; however, the firm declined to comment further on the partnership. "Demand for foundry service does not outstrip Imec's capability as we also offer a collaboration with a partner foundry for high-volume production," the spokesperson said.

Once the chips' manufacturing process and design is finalized, Roswell will have to go back and adjust its chemistry to it. "Whatever the chemistry is, we know how to industrialize chemical production," Merriman said.

Roswell remains on track despite the general challenges of operating in the COVID-19 pandemic. The firm's biggest problems have been with its supply chain and being able to operate at capacity on its chemistry, whose development continues in parallel to the chip manufacturing process.

And while the firm was founded to enable precision medicine, Mola and Merriman see a role for the company in the pandemic response.

"We are exploring getting funding to develop a global surveillance technology that's simple to use, fast, and deployable in environmental surveillance of these pandemics," Mola said. The firm is seeking coronavirus-related funding from the US government to strike out in that direction. The platform enables not just sequencing but also genotyping and binding assays, which could be simpler to develop and market for this purpose.

In addition to molecular testing, Roswell's technology could be used to read DNA in DNA data storage applications. The firm is part of a group led by the Georgia Tech Research Institute that received $25 million from the Intelligence Advanced Research Projects Activity, the Central Intelligence Agency's version of DARPA, to work on that problem. How much of that funding Roswell will receive is unclear. Other partners in that group include Twist Bioscience and Microsoft.